Recalls / Class II
Class IID-0460-2022
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
- Affected lot / code info
- Lot # 031489A, Expiration 03/31/2022
Why it was recalled
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 31,510 ampules
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-01-05
- FDA classified
- 2022-01-27
- Posted by FDA
- 2022-01-19
- Terminated
- 2022-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0460-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.